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U.S. Department of Health and Human Services

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2003 Warning Letters

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Warning Letters issued in 2003

 

* Not issued: A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

* N/A: Not applicable, the Warning Letter was issued prior to September 1, 2009.

Read more about warning and close-out letters

 
Letter Issue Date Company Name Issuing Office Subject Close Out Date
July 17, 2003 Dairy Production Services [ARCHIVED] Minneapolis District Office Illegal Drug Residue/Animal Tissue/Extra Label Drug Use/Adulterated N/A *
July 17, 2003 Stardell Farms, Inc [ARCHIVED] Kansas City District Office Illegal Drug Residue Animal Tissue/Adulterated N/A *
July 17, 2003 South Texas Blood and Tissue Center [ARCHIVED] Dallas District Office GMP's for Blood, Blood Components/Finished Pharmaceuticals N/A *
July 15, 2003 Carl's Seafood, Inc. [ARCHIVED] New York District Office Seafood HACCP/Adulterated N/A *
July 14, 2003 Riverside Food Manufacturing Corporation [ARCHIVED] Los Angeles District Office Seafood HACCP/Adulterated N/A *
July 14, 2003 Biotronik, Inc. [ARCHIVED] Seattle District Office Medical Devices Reports of Correction & Removals N/A *
July 14, 2003 Mercy Medical Center [ARCHIVED] Baltimore District Office Mammography Quality Standards N/A *
July 14, 2003 Central Valley Large Animal [ARCHIVED] San Francisco District Office Extralabel Drug Use in Animals/Adulterated N/A *
July 14, 2003 Carlson, Steven L., D.V.M. [ARCHIVED] San Francisco District Office Illegal Drug Residue/Animal Tissue/Extra Label Drug Use/Adulterated N/A *
July 14, 2003 Bayou Vista Dairy [ARCHIVED] San Francisco District Office Illegal Drug Residue Animal Tissue/Adulterated N/A *
July 14, 2003 Breast Imaging at Mercy Medical Center [ARCHIVED] Baltimore District Office Mammography Quality Standards Act N/A *
July 13, 2003 Clonmel Healthcare Ltd. [ARCHIVED] Center for Drug Evaluation and Research Postmarketing Reporting of Adverse Drug Experience N/A *
July 11, 2003 Custom Label Advance Nutrition [ARCHIVED] Seattle District Office CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated N/A *
July 11, 2003 Solomon's Island Medical Center [ARCHIVED] Baltimore District Office Mammography Quality Standards N/A *
July 11, 2003 Mike's Seafood [ARCHIVED] New England District Office Seafood HACCP/Adulterated N/A *
July 11, 2003 Scion Cardio-Vascular, Inc. [ARCHIVED] Center for Devices and Radiological Health Lacks Approved Premarket Application/Adulterated/Misbranded N/A *
July 11, 2003 Wescor, Inc. [ARCHIVED] Denver District Office Quality System Regulation/Adulterated N/A *
July 11, 2003 Magnu Vu [ARCHIVED] Los Angeles District Office GMP Requirements for the Quality System Regulation/Adulterated N/A *
July 11, 2003 Edan Naturals, LLC [ARCHIVED] Minneapolis District Office Food Labeling/Misbranded N/A *
July 11, 2003 Frank & Liduina Barcellos Dairy [ARCHIVED] San Francisco District Office Illegal Drug Residue Animal Tissue/Adulterated N/A *



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Contact FDA

ICECI Warning Letters

Division of Freedom of Information (HFI-35)

Food and Drug Administration

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